Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly (POINT)

Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial

The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. Participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. The two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Pulmonary Complication
• Intervention / Treatment: Dietary supplement: immunonutrition supplement of ORAL IMPACT™; Other: oral chlorhexidine decontamination

Detailed Description

This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.

• Study Type: Interventional
• Enrollment (Estimated): 592
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu Che, Dr; Phone Number: 69152020; Email: tracymaobao@126.com

Study Locations

• China
  • Peking, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Lu Che, M.D; Email: tracymaobao@126.com
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Chaolei Liu; Email: verna521@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age≥65 years;
2. undergoing major non-cardiac surgery;
3. scheduled for general anesthesia and endotracheal intubation;
4. American Society of Anesthesiologists (ASA) physical status classification I-IV;
5. with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;
6. informed consent obtained.

Exclusion Criteria:

1. emergency surgery;
2. preoperative pneumonia;
3. allergic to chlorhexidine;
4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
5. expected intervention of immunonutrition<3 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD); Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.	Dietary supplement: immunonutrition supplement of ORAL IMPACT™; For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.; Other: oral chlorhexidine decontamination; For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
Experimental: Group B (immunonutrition and routine oral care, IN&RC); Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily.	Dietary supplement: immunonutrition supplement of ORAL IMPACT™; For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
Experimental: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD); Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.	Other: oral chlorhexidine decontamination; For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
No Intervention: Group D (routine nutrition advice and routine oral care, RN&RC); Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive routine oral care which is routine toothbrushing twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pulmonary complications	composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.	within 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pneumonia	defined according to the US Centers for Disease Control Definition	within 7days and 30 days after surgery
postoperative pulmonary complications	composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.	within 30 days after surgery
postoperative infectious complications	composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.	within 7days and 30 days after surgery
postoperative complications	defined using comprehensive complication index	within 7days and 30 days after surgery
postoperative recovery	assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0	within 7days and 30 days after surgery
hospitalization expenses	total expense during the hospital stay	upon hospital discharge, typically 1-2 weeks
length of hospital stay	days of in hospital stay	upon hospital discharge，typically 1-2 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The Second Hospital of Hebei Medical University; Peking University International Hospital; Guizhou Provincial People's Hospital; Fujian Provincial Hospital; Ningbo No.2 Hospital; Shenzhen Qianhai Shekou Free Trade Zone Hospital
• Investigators: Principal Investigator: Yuguang Huang, Dr, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: immunonutrition; postoperative pulmonary complications; oral decontamination
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine
• Other Study ID Numbers: I-23PJ953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be available from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: 6 months after publication of study results.
• IPD Sharing Access Criteria: Data will be available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No